Long Term F/U Studies at Y5&6 to Demonstrate the Equivalence of 2 Vaccination Schedules of Combined Hepatitis A & B Vaccine
Phase 3
Completed
- Conditions
- Hepatitis BHepatitis A
- Registration Number
- NCT00197171
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
To evaluate the persistence of immune response 5 years and 6 years after the first vaccine dose.
- Detailed Description
Open, randomised, long-term antibody persistence studies, conducted in 2 centers. Immune persistence was compared between subjects who received two doses of GSK Biologicals combined hepatitis A and hepatitis B vaccine at either 0, 6 month schedule or 0, 12 month schedule. These long-term follow-up studies involved taking blood samples at approximately 5 and 6 years after the primary vaccination of combined hepatitis A and B vaccine, to assess antibody persistence and a retrospective safety follow-up.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 143
Inclusion Criteria
- Subjects who received GSK Biologicals' combined hepatitis A and B vaccine in the primary study (HAB-082). Subjects were aged 12 to 15 years at the time of the first vaccination.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Immune persistence in terms of anti-HAV and anti-HBs antibodies and GMCs, 5 and 6 years after administration of first vaccine dose. An additional dose of the study vaccine will be given (between 6 to 12 months after the Year 6 time point) to subjects who
- Secondary Outcome Measures
Name Time Method To record the SAEs that was reported since the last time point.
Trial Locations
- Locations (1)
GSK Investigational Site
🇦🇺Melbourne, Victoria, Australia